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Orange Lantern lantern

Time:2016-01-25 | View3938 | Author:
Orange Lantern lantern
Clean room (area) of the pharmaceutical engineering to particulate and microbial control as the main object, should also control pharmaceutical clean room (area) of the environment temperature, humidity, pressure difference, illumination, noise and other parameters, meet the pharmaceutical production of every step of the process requirements, so as to achieve the ambient air with no odor and impede the drug quality and human health of gas.


In the 2010 version of GMP in the pharmaceutical engineering of the clean level of a Class A, B, C, D four levels, each level has a different process parameters. According to the requirements of the production process clean distinction for 4 levels: a high risk operating area, usually with a laminar flow operating table (cover) to maintain the area of the air environment. Laminar flow system in the work area must be uniform wind, wind speed is 0.36 ~ 0.54m/s (guidance value), the data should prove that the state of laminar flow and must be verified. At a closed operation isolation or glove box, and can be used for one-way flow or lower wind speed; B refers to the aseptic preparation and filling, high risk operation grade a zone in which the background region; grade C and D to sterile drug production process in lower degree of importance of clean operating area. A, B, C level on the static and dynamic requirements, D only to the static requirements. In summer, in the production process on the temperature and humidity has no special requirements, air cleanliness a (b) level, C class pharmaceutical clean room (area) temperature should 20 to 24 DEG C, the relative humidity should be 45% to 60%; the temperature of the air cleanliness class D for the 18 to 26 degrees Celsius relative humidity should be 45% to 65%. Pharmaceutical engineering has sterile drug production, non sterile drug production, raw materials, pharmaceutical production, Chinese medicine preparation, etc..

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